Moms Managing Attention-Deficit/Hyperactivity Disorder (ADHD) Study
- Conditions
- ParentingADHD
- Interventions
- Behavioral: MomMA Intervention
- Registration Number
- NCT06540547
- Lead Sponsor
- University of Pittsburgh
- Brief Summary
The study will develop and test a behavioral program for pregnant individuals with Attention-Deficit/Hyperactivity Disorder (ADHD). This behavioral program will include skills for managing ADHD and related symptoms during pregnancy and after delivery and will be taught by a behavioral therapist in OB care settings.
- Detailed Description
Treating pregnant individuals with ADHD may improve parent and child wellbeing, parent-child interactions, and psychosocial familial factors to enhance family resilience and reduce prevalence/severity of child mental health disorders. Using the information provided from stakeholder interviews and adaptations of an existing CBT intervention for parents of children with ADHD, the current study will develop the MomMA (Moms Managing ADHD) intervention and implement it via an open clinical trial (n=10 pregnant individuals), delivered by masters-level women's health behavioral therapists. Investigators will examine treatment acceptability, feasibility, and appropriateness, as well as implementation factors (fidelity, adherence, facilitators/barriers) and qualitative data (e.g., feedback interviews). In addition, quantitative data (self-reported symptoms, parenting, and home environment measures; observed parent and child behavior; parent reported child temperament/behavior) will be used to assess parent and child outcomes following the intervention. This mixed-methods model will offer a comprehensive examination of the MomMA intervention and inform a refined intervention model.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 10
- (1) meet full DSM-5 criteria for ADHD
- (2) are between 20- and 32-weeks of gestation
- (3) speak English
- (4) will deliver at the University of Pittsburgh Medical Center (UPMC) Magee Women's Hospital (MWH)
- (1) active substance use disorder
- (2) intellectual disability
- (3) other severe mental illness, including bipolar disorder, psychosis, and major depressive disorder with suicidal ideation or requiring higher level of care (inpatient or partial/intensive outpatient)
- (4) high risk pregnancies requiring transfer of care to Maternal-Fetal Medicine (e.g., maternal cancer, multiples, placenta accreta) and/or fetus known to have a severe congenital condition.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description MomMA Intervention MomMA Intervention -
- Primary Outcome Measures
Name Time Method Intervention Appropriateness Post Intervention at 4-month postpartum Therapist and participant report of intervention appropriateness will be assessed using the 4-item Intervention Appropriateness Measure (IAM), rated from 1 (completely disagree) to 5 (completely agree), with scores greater than or equal to 16 indicating good appropriateness.
Intervention Acceptability Post Intervention at 4-month postpartum Therapist and participant report of intervention acceptability will be assessed using the 4-item Acceptability of Intervention Measure (AIM), rated from rated from 1 (completely disagree) to 5 (completely agree), with scores greater than or equal to 16 indicating good acceptability.
Intervention Feasibility Post Intervention at 4-month postpartum Therapist and participant report of intervention feasibility will be assessed using the 4-item Feasibility of Intervention Measure (FIM), rated from 1 (completely disagree) to 5 (completely agree), with scores greater than or equal to 16 indicating good feasibility.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
UPMC Magee Women's Hospital
🇺🇸Pittsburgh, Pennsylvania, United States